• Feature ArticlesFeature Articles

    Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes

    This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement. Introduction Wearable technologies and mobile Health (mHealth) devices are increasingly helping patients report meaningful outcomes and manage their conditions while enhancing their quality of life. Wearable technologies are "smart" electronic devices...
  • Regulatory NewsRegulatory News

    OPDP Study Raises Questions About the Balance of Information in Mobile Ads

    A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs. As with other mediums for drug advertising, including print, television, web and social media, the study finds that mobile ads tend to present the benefits of drugs more prominently than their risks. "This echoes prior research across a broad range o...
  • Regulatory NewsRegulatory News

    Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

    The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology. Such mobile technology can offer new ways to collect objective measurements of clinical trial participants as they go about their daily lives. And though the use of such novel endpoints, whi...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

    The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...
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    Popular RAPS App Back Again for 2016 Regulatory Convergence

    If you will be attending RAPS’ Regulatory Convergence in San Jose next month, go download the RAPS Events app for your smart phone now. The app was unveiled for the first time at last year’s Convergence in Baltimore and it proved to be a runaway hit. Users found it useful, fun and intuitive. Last year, Convergence veterans and first-timers alike used the app to engage with one another, share photos, observations and takeaways from the sessions they attended ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Updates Guidance on Determining Whether an app is a Medical Device The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software developers understand whether an app needs a CE mark. MHRA released ...
  • Regulatory NewsRegulatory News

    FDA Declares ‘General Wellness’ Devices Exempt From Regulations

    The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements. Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons." As in the...
  • Regulatory NewsRegulatory News

    Industry Calls for More Guidance From FDA on New Clinical Trials Technology

    The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products. In October 2015, FDA put out a request for more information on the types of technologies and innovations companies are employing to conduct clinical rese...
  • Regulatory NewsRegulatory News

    FDA Collaborates With FTC on Mobile Health App Regulatory Tool

    The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws. As part of that compliance push, FTC on Tuesday released  a new web-based tool for developers of health-related mobile apps .  The tool asks developers a series of high-level questions about the app’s function, the da...
  • Regulatory NewsRegulatory News

    EU Looks to Improve Data Quality of mHealth Apps

    The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health. The working group comes as such lifestyle and well-being mHealth (everything from step trackers to heart rate analyzers to weight-loss helpers) has skyrocketed to more than 100,000 apps...
  • Regulatory NewsRegulatory News

    FDA Seeks Info on New Tech Helping Conduct Clinical Research

    The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research. The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it's requesting more information on the challenges associated with collecting data on trial participants' own devices, which FDA says may be used to access and respond to ...
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    Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes

    Starting today, you will be able to download the new RAPS Events mobile app for Apple and Android devices. The app has been customized for the 2015 Regulatory Convergence conference, taking place 24–28 October in Baltimore, where attendees will get the first chance to try it out. Convergence attendees will be able to use the app on mobile devices to find information about Convergence sessions, speakers, events and activities; share their own photos and comments...